CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S— 510(k) K902492

Name: FDA 510(k) clearance K902492
Creator: U.S. Food and Drug Administration
Published: 1990-07-06

Substantially Equivalent

Datex Division Instrumentarium Corp.

FDA 510(k) clearance K902492 for CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S, Substantially Equivalent on 1990-07-06. Applicant: Datex Division Instrumentarium Corp.. Device class: 1.

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Code DRI
Device class: Class 1
Regulation: 21 CFR 870.2620
Advisory panel: Cardiovascular
Date received: 1990-06-05
Decision date: 1990-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, Finland, FI

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